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Navik 3D

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152160

by Apn Health, LLC

Identifiers

510(k) Number
K152160 FDA 510(k)
FDA Product Code
DQK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Navik 3D is a 3D cardiac mapping system, designed to provide real-time electrophysiological guidance for cardiovascular interventions. It generates detailed anatomical, electrical activation, and voltage maps of the heart to support precise procedural planning and execution in electrophysiology.

This device is supplied as a software platform integrated with compatible electrophysiology systems and is intended for use in clinical settings by trained healthcare professionals. It is a reusable, non-sterile system with FDA 510(k) clearance under the traditional review pathway, classified under product code DQK for cardiovascular devices. No specific MRI safety or sterility requirements are noted in the provided data.

Frequently asked questions

What types of cardiovascular procedures can the Navik 3D system support during electrophysiological interventions?

The Navik 3D system is designed to provide real-time electrophysiological guidance for cardiovascular interventions by generating detailed 3D anatomical and electrical maps of the heart. This includes voltage and activation mapping, which helps clinicians plan and execute procedures like catheter ablation, mapping of arrhythmias, and other electrophysiology studies where precise anatomical and electrical data are critical.

How is the Navik 3D system supplied, and is it reusable or single-use?

The Navik 3D is supplied as a reusable software platform integrated with compatible electrophysiology systems. It is not a sterile device, so it is intended for use in clinical settings where proper cleaning and maintenance protocols are followed between procedures. The system itself is not disposable, but its associated consumables (like catheters or mapping tools) may follow single-use guidelines depending on the manufacturer’s specifications.

Does the Navik 3D system require any special handling or storage conditions?

Since the Navik 3D is a reusable, non-sterile software platform, it does not have specific sterility or MRI safety requirements mentioned in the data. However, it should be stored in a clean, controlled environment to prevent contamination and ensure optimal performance. The system’s hardware components should follow the manufacturer’s guidelines for maintenance, calibration, and software updates to maintain accuracy and reliability.

What regulatory pathway was used for the FDA clearance of the Navik 3D system?

The Navik 3D system received FDA clearance through the traditional 510(k) review pathway, classified under product code DQK for cardiovascular devices. The clearance was granted under the Cardiovascular (CV) advisory committee and was determined to be substantially equivalent to a predicate device, as indicated by the decision code SESE (Substantially Equivalent, Same Endpoints).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Navik AI | AI-Enabled Electrophysiology Platform | APN Health, APN Website, APN Health Receives FDA Clearance for Innovative Cardiac Mapping System, APN Website

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Apn Health, LLC

Sources (1)

  • FDA 510(k) K152160 24 fields · synced Sep 19, 2026